NDA 20305, held by Roche. Granisetron Hydrochloride.
As of Nov 13, 2026, NDA 20305 (Kytril), held by Roche, was first approved by FDA on Mar 16, 1995, with 9 approved supplements and 0 published complete response letters.
| Jul 27, 1999 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Oct 6, 1997 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Mar 16, 1995 | Original applicationNew dosage form · Standard review | Approved | None posted |
| KytrilEQ 1MG BASE **Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons** · tablet;oral | Granisetron Hydrochloride | DiscontinuedReference drug |
| KytrilEQ 2MG BASE **Federal Register determination that product was not withdrawn or discontinued for safety or effectiveness reasons** · tablet;oral | Granisetron Hydrochloride | DiscontinuedReference drug |
| Oct 7, 2009 | Supplement 14Labeling · Standard review | Approved | |
| Nov 23, 2005 | Supplement 10Labeling · Standard review | Approved | |
| Nov 25, 2002 | Supplement 8Manufacturing · Standard review | Approved | None posted |
| Nov 5, 2002 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Nov 5, 2002 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Jul 27, 1999 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Jun 15, 1998 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Oct 6, 1997 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Oct 24, 1996 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Mar 16, 1995 | Original applicationNew dosage form · Standard review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
